BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 16265307 · Received January 30, 2023

    Report

    Report Number
    3002808148-2023-00885
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    January 4, 2023
    Report Date
    March 3, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    GCJ
    UDI-DI
    04953170363498
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION. DURING EVALUATION, IT WAS OBSERVED, THE DEVICE HAD DISCOLORED REAR PANEL AND CRACKED BEZEL. THE INVESTIGATION IS ONGOING, AND A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION ON EVALUATION FINDING, ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION, AND A DEVICE HISTORY RECORD (DHR) REVIEW. ADDITIONAL EVALUATION FINDING WAS IDENTIFIED INDICATING THE DEVICE HAD NO IMAGE DUE TO FAULTY QUANTUM BOARD (QB). A REVIEW OF THE DHR FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE REPORTED ISSUE OCCURRED DUE TO A MALFUNCTION OF AN INTERNAL BOARD. HOWEVER, THE ROOT CAUSE COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, DURING A COLONOSCOPY PROCEDURE, THE HIGH-DEFINITION LCD MONITOR HAD INTERMITTENT STATIC IMAGE. IT WAS NOTED, THE PROCEDURE WAS DELAYED BY A FEW MINUTES BUT DID NOT NEED TO BE CANCELED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070097 HIGH DEFINITION LCD MONITOR IMAGE DISPLAY UNIT, COLOUR GCJ SHIRAKAWA OLYMPUS CO., LTD. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown